BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCP PANEL CENTRIFUGE JMS

    MDR report key: 3488870 · Received November 5, 2013

    Report

    Report Number
    1718850-2013-00240
    Event Type
    Other
    Date Received
    November 5, 2013
    Date of Event
    September 30, 2013
    Report Date
    October 8, 2013
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE SCP PANEL CENTRIFUGE JMS, WHICH IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO THE STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP. THE 510(K) NUMBER OF THE STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP IS K032213. THE INCIDENT OCCURRED IN (B)(6). (B)(4). THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT IT WAS DIFFICULT TO CONTROL THE FLOW RATE WITH THE KNOB OF THE SCP PANEL CENTRIFUGE DURING SET UP. THE CLINICIAN REPLACED THE CONTROL PANEL PRIOR TO STARTING THE PROCEDURE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569709 SCP PANEL CENTRIFUGE JMS PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE DWA SORIN GROUP DEUTSCHLAND 60-02-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA